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Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men

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ClinicalTrials.gov Identifier: NCT03760757
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Tim Mickleborough, Indiana University

Brief Summary:
To evaluate the effects of PCSO-524®, and a blend of PCSO-24® (75%) and krill oil (25%) (ESPO-572®), on indirect markers of muscle damage, inflammation and soreness during recovery from muscle damaging exercise in untrained men.

Condition or disease Intervention/treatment Phase
Inflammation; Muscle Dietary Supplement: ESPO-572® Dietary Supplement: PCSO-524® Not Applicable

Detailed Description:
The study will be conducted as a randomized, parallel group trial over 29 days. A total of 50 untrained male subjects will participate in this study. Subjects will be classified as 'untrained' if they exercise less than three times per week for less than 30 min during each session. Subjects will be randomly assigned to either a green-lipped mussel oil blend (PCSO-524® supplementation group, n = 25) or a 75/25% PCSO-24®/Krill oil blend group (ESPO-572® supplementation group, n = 25). Supplementation will begin 26 days before an eccentric exercise bout (downhill running, designed to induce muscle damage and continue for 3 days following the muscle damaging exercise bout).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled non-inferiority trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effectiveness of Two Different Forms of Marine Oil, Derived From the New Zealand Green Lipped Mussel and Krill Oil, on Indirect Markers of Muscle Damage and Soreness During Recovery From Muscle Damaging Exercise in Untrained Men
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: PCSO-524® (no krill oil)
Four total capsules per day (2 in the morning; 2 at night) for 29 days. Amounts per day equal to 800 mg olive oil, 400 mg lipid extract (~58 mg EPA and 44 mg DHA) and 1.8 mg vitamin E (d-alpha-tocopherol).
Dietary Supplement: PCSO-524®
PCSO-524® (Lyprinol®/Omega XL®) is a nutritional supplement containing a patented extract of highly condensed form of stabilized marine lipids from the New Zealand green lipped mussel (Perna canaliculus) that is combined with olive oil and vitamin E. This marine oil lipid and omega-3 polyunsaturated fatty acid (PUFA) blend is a diverse mixture of sterol esters, sterols, polar lipids, triglycerides, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (split between the triacylglycerol and polar lipid classes), and free fatty acids.

Experimental: ESPO-572® (75% PCSO-524®, 25% krill oil)
Four total capsules per day (2 in the morning; 2 at night) for 29 days. ESPO-572®, a 75/25% PCSO-24®/Krill oil blend. Each capsule of the ESPO-572® contains green lipped mussel oil, krill oil, olive oil and vitamin E.
Dietary Supplement: ESPO-572®
ESPO-572® is the same as PCSO-524®, except it has krill oil added to it.




Primary Outcome Measures :
  1. Creatine Kinase [ Time Frame: Four days ]

    Muscle damage markers: Muscle creatine kinase will be measured using a Beckman DU® Spectrophotometer (Beckman Coulter Inc., Brea, CA) at 360nm using a fluorometric assay kit (Cayman Chemicals, Ann Arbor, MI).

    Units: ng/mL


  2. Skeletal muscle slow troponin I [ Time Frame: Four days ]

    Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO).

    Units: ng/mL


  3. Interleukin-1 Beta [ Time Frame: Four days ]

    Muscle inflammation markers: Interleukin-1 Beta (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA).

    Units: pg/mL


  4. Tumor necrosis factor-alpha [ Time Frame: Four days ]

    Muscle inflammation markers: Tumor necrosis factor-alpha (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA).

    Units: pg/mL


  5. Isometric torque [ Time Frame: Four days ]

    Isometric torque: Isometric torque assessment of the dominant leg extensors will be conducted at a knee angle of 80°flexion (measured by a goniometry) using a Cybex Isokinetic System (Medway, MA).

    Units: Nm


  6. Range of motion [ Time Frame: Four days ]

    Measurement of knee flexion range of motion

    Units: degrees


  7. Swelling [ Time Frame: Four days ]

    Limb girth measurements are used to test for the presence of swelling/edema within a muscle.

    Units: percentage change from baseline


  8. Delayed onset muscle soreness [ Time Frame: Four days ]

    Visual analog scale of muscle soreness (delayed onset muscle soreness; DOMS) - Knee extensor soreness will be assessed using a visual analogue scale with "no soreness" indicated at one end (score 0) and "unbearably painful" at the other (score 10).

    Units: Arbitrary units


  9. Pressure pain threshold [ Time Frame: Four days ]

    A hand-held pressure algometer (Algometer®, Somedic Sales, Hörby, Sweden) will be used to monitor pressure induced pain at five specific sites on the quadriceps.

    Pressure pain threshold units: percentage change from baseline




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will include males (18 to 30 years), determined to be low risk (as determined by ACSM's Guidelines for Exercise Testing and Prescription (American College of Sports Medicine., Thompson, Gordon, & Pescatello, 2010)
  • BMI<30 (not obese) by a modified physical activity readiness questionnaire (PAR-Q),
  • Classified as 'untrained' defined by not habitually exercising more than 3x/week. In order to participate subjects would be allowed to exercise not more than three days a week. Each of the exercise sessions must not be longer than 30 minutes and cannot include downhill or uphill running.

Exclusion Criteria:

  • History of asthma or exercise-induced asthma, COPD, interstitial lung diseases, or cystic fibrosis, dyspnea
  • History of downhill running training or other eccentric endurance exercise within the past 3 months
  • History of fish oil or other omega-3 nutritional supplements within the last 3 months
  • History of significant pain in hips or knees
  • Current participation in a strength training program or having participated in a strength training program within 60 days before the study
  • Regular use of anti-inflammatory medication or nutritional supplements (e.g. ketorolac, celecoxib, creatine, protein drinks, amino acids, fish oil or vitamins)
  • Current daily use of anti-inflammatory medication such as Tylenol, Advil, or Aleve.
  • Allergies to fish, seafood, or shellfish
  • Family or personal history of cardiac, peripheral vascular, or cerebrovascular disease.
  • A diabetic or experience shortness of breath as determined by the modified PAR_Q.
  • In addition to screening subjects for known cardiovascular disease, or signs and symptoms of pulmonary metabolic disease, subjects will be excluded if their values are outside ACSM's guidelines for cardiovascular disease risk as outlined in Figure 2. This would place subjects as low risk. Researchers will be screening based on age, family history of heart attacks, exposure to cigarette smoke, obesity, hypertension, dyslipidemia and pre-diabetes. Since subjects are recruited as sedentary, this a positive risk factor for CVD. Subjects will be screened for dyslipidemia and will be accepted into the study if their values are for low-density lipoprotein (LDL-C) cholesterol less than 130 mg dL-1 (3.37 mmol·L-1) or a total serum cholesterol value of less than 200 mg·dL-1 (5.18mmol L-1) or and HCL-C is greater or equal to 40 mg·dL-1 (1.55mmol L-1). Please note that this will not change the subjects risk status and they will be still classified as low risk. Subjects should not be currently taking and cholesterol lowering medication such as: Atorvastatin (Lipitor), Fluvastatin (Lescol), Lovastatin (Mevacor), Pravastatin (Pravachol), Simvastatin (Zocor), Rosuvastatin (Crestor)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760757


Contacts
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Contact: Matthew J Barenie, M.S. 219-776-6740 matbaren@iu.edu
Contact: Jessica Freemas, M.S. 1-317-850-6100 jfreemas@iu.edu

Locations
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United States, Indiana
Indiana University School of Public Health Recruiting
Bloomington, Indiana, United States, 47405
Contact: Timothy D Mickleborough, PhD    812-855-0753    timickleb@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Timothy D Mickleborough, Ph.D. Indiana University

Publications:
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Responsible Party: Tim Mickleborough, Professor, Kinesiology, Indiana University
ClinicalTrials.gov Identifier: NCT03760757     History of Changes
Other Study ID Numbers: 1809579862
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tim Mickleborough, Indiana University:
krill oil
DOMS
EIMD (exercise induced muscle damage)
Additional relevant MeSH terms:
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Myositis
Inflammation
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Vitamins
Vitamin E
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents